Sr Manager / Manager, Global Regulatory Affairs CMC - Virtual
Takeda Pharmaceutical
New York, New York
manager
regulatory
cmc
virtual
regulatory
cmc
health
team
r&d
patients
manager
lead
moderate
November 22, 2022
Takeda Pharmaceutical
New York, New York
- About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.
- By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
- Join Takeda as a Senior Manager/Manager, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products.
- You will also with moderate guidance, communicate and negotiate with international Health Authorities, directly and indirectly.
- As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
- How you will contribute: Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
- As a GRA CMC product leader or team member, ensures and enhances regulatory compliance for filing requirements for assigned compounds throughout development and the commercial life cycle.
- Independently define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- With moderate guidance, represents Takeda RA CMC in Health Authority meetings and leads CMC preparation activities for meetings with Health Authorities on CMC related matters.
- Interact directly with international Health Authorities.
- Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success.
- Foster constructive working relationships when working with all colleagues.
- Evaluate change proposals for global regulatory impact.
- and plans global variations and amendments.
- What you bring to Takeda: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 4 years pharmaceutical Regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience.
- (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
- Able to deal with issues of essential importance.
- Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrate new leadership, problem-solving ability, attention to detail, flexibility and values teamwork.
- Exercise good judgement in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills.
- Active participation in Agency/Industry groups/forums preferred.
- Base Salary Range: $101,500 to $145,000 based on candidate professional experience level.
- Employees may also be eligible for Short Term and Long-Term Incentive benefits as well.
- Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
- More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
- Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
- Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
- We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
- No Phone Calls or Recruiters Please.
- Locations USA - MA - Virtual Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time LI-Remote
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